Overactive bladder and anxiety
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Outpatients or inpatients female patients aged 18–65 years with a disease duration of more than 2 months; Meeting the diagnostic criteria for overactive bladder (OAB) as defined in the Chinese Guidelines for the Diagnosis and Treatment of Urological Diseases (2025 edition); Classified as the Kidney Deficiency with Damp-Heat syndrome according to traditional Chinese medicine (TCM) differentiation; Capable of using a voiding diary; OAB Symptom Score (OABSS) between 3 and 11 (inclusive); OABSS = 2 is considered asymptomatic thus only patients with mild to moderate OAB are included. Hamilton Anxiety Scale (HAMA) scores between 7 and 29 (inclusive) indicating mild to moderate anxiety symptoms; Providing informed consent voluntarily. The informed consent process must comply with Good Clinical Practice (GCP) guidelines.
Exclusion criteria
Exclusion criteria: 1) Patients with acute infections or urinary tract infections; 2) Patients with bladder pain syndrome interstitial cystitis; pregnant breastfeeding or planning to become pregnant; patients with severe hypertension or unstable blood pressure control; patients with severe heart brain liver kidney or blood diseases; 3) Patients with contraindications to acupuncture; those with a history of needle phobia and fear or resistance to acupuncture treatment; 4) Exclude patients with OABSS (Overactive Bladder Symptom Scale) =12 (severe OAB) or OABSS =2 (no OAB) or HAMA (Hospital Anxiety and Munchausen's Hypochondriac Checklist) =30 (severe anxiety) or HAMA =6 (no anxiety); 5) Patients with skin allergies or other skin conditions; 6) Patients diagnosed with anxiety disorder or depression.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serotonin levels in the blood;Daytime frequency urgency frequency and nocturia frequency;Anxiety relief response rate;Overactive Bladder Symptom Score ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Traditional Chinese Medicine symptom score and efficacy evaluation;Maximum urine flow rate and residual urine volume and maximum bladder capacity;Hamilton Depression Rating Scale and Pittsburgh Sleep Quality Index ;International Incontinence Consultation Questionnaire-Overactive Bladder Questionnaire ;Serum neutrophil-to-lymphocyte ratio (NLR); | — |
Countries
China
Contacts
Jiangsu Province Academy of Traditional Chinese Medicine